Actively Recruiting
TIL Therapy Combined With Pembrolizumab for Advanced Brain Cancer Including Gliomas and Meningiomas
Led by Essen Biotech · Updated on 2024-11-05
85
Participants Needed
1
Research Sites
114 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This Phase I/II study evaluates the safety and efficacy of autologous tumor-infiltrating lymphocytes (TIL) therapy combined with Pembrolizumab (Keytruda) immunotherapy in patients with Advanced Brain Cancer including Gliomas and Meningiomas . Lifileucel (Amtagvi), the first FDA-approved TIL therapy, has demonstrated significant success in treating unresectable or metastatic melanoma by utilizing the patient's own immune cells to combat cancer. This study aims to apply a similar approach to Brain cancer. TILs will be harvested from patients' tumors, expanded in vitro, and infused back into the patients following a non-myeloablative lymphodepletion regimen. Pembrolizumab, a monoclonal antibody targeting the PD-1 receptor on T cells, will be administered to enhance the immune response. The primary endpoint is to determine the objective response rate (ORR) of this combined therapy. Secondary endpoints include disease control rate (DCR), progression-free survival (PFS), overall survival (OS), duration of response (DOR), and quality of life (QoL). This trial aims to offer a novel, personalized treatment option for patients with limited therapeutic alternatives.
CONDITIONS
Official Title
TIL Therapy Combined With Pembrolizumab for Advanced Brain Cancer Including Gliomas and Meningiomas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 16 and 90 years
- Histological diagnosis of primary, relapsed, or metastatic brain glioma
- Expected life expectancy of more than 3 months
- Karnofsky score of 60% or higher or ECOG score between 0 and 2
- Failure of standard treatment regimens or no standard treatments available
- Presence of tumor areas suitable for biopsy or resection, or malignant fluid for TIL isolation
- At least one tumor lesion that can be evaluated
- Blood tests within 7 days before enrollment meeting specific counts: white blood cells ≥2.5x10^9/L, neutrophils ≥1.5x10^9/L, lymphocytes ≤0.7x10^9/L, platelets ≥100x10^9/L, hemoglobin ≥90 g/L
- Coagulation tests within limits unless recent anticoagulant therapy
- Kidney and liver function tests within specified limits
- No absolute or relative contraindications to surgery or biopsy
- Willingness to use effective contraception for one year after lymphodepletion if of child-bearing potential
- No cancer-targeting therapies (radiotherapy, chemotherapy, biologics) within 28 days before TIL collection
- Ability to understand and sign informed consent
- Willingness to follow study visit plans and requirements
You will not qualify if you...
- Need for glucocorticoid treatment with prednisone greater than 15 mg daily or immunomodulatory treatment for autoimmune diseases
- Lung function with FEV1 less than 2 liters or DLCO less than 40%
- Significant heart problems including severe heart failure, uncontrolled coronary artery disease, low ejection fraction (<35%), or serious arrhythmias
- Positive tests for HIV, active hepatitis B or C, syphilis or related antibodies
- Severe physical or mental illness
- Active systemic infections requiring treatment or positive blood cultures
- Use of other medications, biologics, chemotherapy, or radiotherapy within the past month or current treatment
- Allergy history to similar chemical or biological substances used in cell therapy
- Prior immunotherapy with immune-related adverse events worse than grade 3
- Unresolved adverse effects from prior anti-tumor treatments above grade 1 (excluding alopecia)
- Pregnant or breastfeeding females
- History of organ transplantation, allogeneic stem cell transplantation, or renal replacement therapy
- Other severe systemic diseases or reasons deemed inappropriate by researchers for trial participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
District One Hospital
Beijing, Beijing Municipality, China, 086-373
Actively Recruiting
Research Team
R
Rhoda M Smith, Phd
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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